PCSK9 is a protein that targets LDL receptors for degradation; its inhibition thereby enhances the liver's ability to remove LDL-C, often colloquially referred to as "bad" cholesterol, from the blood.
[13] The FDA approved evolocumab injection on 27 August 2015, for some patients who are unable to get their LDL cholesterol under control with current treatment options.
The question before the US Supreme Court is "Whether enablement is governed by the statutory requirement, that the specification teach those skilled in the art to “make and use” the claimed invention, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”[20] Other commentators believe, that the SCOTUS took the case, because of the significance of the legal question, which is deemed comparable to the impact of KSR v. Teleflex.
However, Amgen was able to convince the USPTO to issue a patent, that broadly claims yet-unmade antibodies with a high affinity to the discovered antigen.
The purposivism justification for disallowing such broad poorly-enabled claims is to allow other pharmaceutical companies to develop other (and potentially better) drugs, that target the same receptor.
However, the drawback of such narrow interpretation, is the resulting reluctance of the antigen discoverers to share their finding with the World, because such early disclosure would prevent them from reaping the maximum profits from their discovery, which they could obtain by developing multiple medications, and keeping them secret for many years.